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Effect of cardiac rehabilitation on cardiorespiratory fitness and adherent factors after percutaneous coronary intervention

Status Approved

  • First Submitted Date

    2018/11/04

  • Registered Date

    2019/03/25

  • Last Updated Date

    2019/02/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003663
    Unique Protocol ID WKUH 2018-02-054
    Public/Brief Title Effect of cardiac rehabilitation after myocardial infarction
    Scientific Title Effect of cardiac rehabilitation on cardiorespiratory fitness and adherent factors after percutaneous coronary intervention
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number WKUH 2018-02-054
    Approval Date 2018-04-05
    Institutional Review Board Name Wonkwang University Hospital Institutional Review Board
    Institutional Review Board Address 895, Muwang-ro, Iksan-si, Jeollabuk-do
    Institutional Review Board Telephone 063-859-2232
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name MINSU KIM
    Title Doctor
    Telephone +82-63-859-1610
    Affiliation Wonkwang University Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Public Queries
    Name MINSU KIM
    Title Doctor
    Telephone +82-63-859-1610
    Affiliation Wonkwang University Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Updating Information
    Name MINSU KIM
    Title Doctor
    Telephone +82-63-859-1610
    Affiliation Wonkwang University Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-04-09 Actual
    Target Number of Participant 44
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Wonkwang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-04-09 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Wonkwang University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Wonkwang University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Coronary heart disease (CHD) is one of the leading causes of death worldwide, accounting for one third of all deaths. Cardiac rehabilitation decreases cardiac and all-cause mortality and reduces cardiovascular risk factors. In addition, cardiac rehabilitation in patients with myocardial infarction is known to significantly improve the cardiopulmonary function and exercise capacity, improve quality of life, and promote social functioning. Therefore, cardiac rehabilitation is an important support program for the recovery and secondary prevention of coronary heart disease. Both the American College of Cardiology and the European Society of Cardiology advocate CR for patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting.
    However, despite the benefits of cardiac rehabilitation, the rate of enrollment in cardiac rehabilitation programs around the world remains suboptimal from 20% to 30%, and there are many patients who give up even if they participate in cardiac rehabilitation once. In previous research about participation rates of cardiac rehabilitation, various barriers to cardiac rehabilitation have been identified, such as the lack of awareness of cardiac rehabilitation, time constraints, and inaccessibility. In addition, it was reported that participation rate was low in women, elderly, unemployed, and low educated people. Researches of referral, enrollment rates, and factors affecting participation are essential to increase cardiac rehabilitation participation rates. However, data on enrollment of Asian patients in CR are very limited.
    Meanwhile, a number of studies have documented improvements in functional capacity after cardiac rehabilitation programs in patients with myocardial infarction who were subjected to percutaneous coronary intervention (PCI). Previous studies have reported increase in peak VO2, in the range of 14% to 31% after exercise training. In other studies, exercise tolerance and peak workload were significantly improved after 3 weeks of cardiac rehabilitation, as well as peak VO2, peak VCO2, and peak ventilatory exchange. However, studies about the effect of cardiac rehabilitation on cardiopulmonary function have been rarely reported in Korea.
    Understanding of referral, participation patterns of patients, and the barrier to participation are essential to improving access to cardiac rehabilitation. In addition, the effect of cardiac rehabilitation on the improvement of cardiopulmonary function in patients with myocardial infarction has not yet been studied in Korea. In this study, we analyzed the data of the patients diagnosed with acute myocardial infarction undergoing percutaneous coronary intervention and examine the factors involved in cardiac rehabilitation participation and the effects of cardiac rehabilitation on cardiorespiratory function.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Others (rehabilitation therapy)
    Intervention Description
    The subjects who were diagnosed as acute myocardial infarction and underwent percutaneous coronary intervention were divided into those who participated in cardiac rehabilitation and those who did not. Those participating in cardiac rehabilitation should perform one hour of aerobic exercise training per session, three times a week for six weeks.
    Number of Arms 2
    Arm 1

    Arm Label

    Cardiac rehabilitation group

    Target Number of Participant

    22

    Arm Type

    Experimental

    Arm Description

    CR group perform one hour of aerobic exercise training per session, three times a week for six weeks. Each session consists of 10 minutes of warm-up, 15 minutes of main exercise, 5 minutes of resting exercise, 15 minutes of main exercise and 10 minutes of cool-down. The intensity of the exercise is 60-80% of VO2max. Exercise tolerance test (ETT) is performed at baseline, 3month, and 6 month.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    22

    Arm Type

    No intervention

    Arm Description

    The control group did not participate cardiac rehabilitation, and regular follow up was performed through the outpatient clinic.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I25.1)Atherosclerotic heart disease 

    Cardiac Rehabilitation, Myocardial Infarction, Percutaneous Coronary Intervention
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    30Year~80Year

    Description

    1)In our institution, patients who were diagnosed as acute myocardial infarction and underwent percutaneous coronary intervention
    2)Those who performed the first exercise testing based on treadmill (ETT) evaluation after discharge
    Exclusion Criteria
    1)A person with a medical condition who may be disturbed in the clinical research due to severe or unstable physical illness at the time of selection
    2)Those who refused participation in cardiac rehabilitation and did not perform ETT evaluation.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Maximal oxygen consumption (VO2max)
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 1
    Outcome
    Blood pressure
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 2
    Outcome
    Heart rate
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 3
    Outcome
    Ventilatory threshold
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 4
    Outcome
    Maximal ventilation
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 5
    Outcome
    Maximal tidal volume
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 6
    Outcome
    Maximal oxygen pulse
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
    Secondary Outcome(s) 7
    Outcome
    VE/VCO2max
    Timepoint
    Baseline(Within 2 weeks after discharge), 3month, 6month
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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